Mechanism of Action
Regulatory authorities demand that the efficacy of biologics is supported by its mechanism of action: the composition as it relates to the mode(s) of action should be supported by evidence from the quality, clinical, and non-clinical studies and markers for potency should be identified and demonstrated to be suitably representative and assays validated.
Smart Assays team, has considerable reputation and abilities at untangling elaborate issues such as the mechanism of action. With hands-on experience and a full understanding of the underlying biochemical and biological principles of a given system, our researchers have the ability to bring to a successful completion even the most challenging projects. We generated data which addresses the mechanism of action of the product.
Mechanism of Action
